BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN TB 1 ML 27X1/2

    MDR report key: 1945866 · Received November 29, 2010

    Report

    Report Number
    1915484-2010-00043
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    September 7, 2010
    Report Date
    November 16, 2010
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A TUBERCULIN SYRINGE. THE CUSTOMER REPORTS THAT THE NURSE OPENED THE SEALED PACKAGE CONTAINING A TUBERCULIN SAFETY SYRINGE AND DISCOVERED THAT THE NEEDLE HAD BROKEN OFF AND WAS PROTRUDING OUT OF THE CAP WHILE THE CAP WAS STILL ON THE SYRINGE. THERE WAS NO PT INJURY OR ADVERSE OUTCOME RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGELLAN TB 1 ML 27X1/2 TUBERCULIN SYRINGE FMF COVIDIEN 8881882712 018112

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK